SUMMARY CMI

Sodium Chloride 0.9%

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Sodium Chloride 0.9%?

Sodium Chloride 0.9% contains the active ingredient sodium chloride. Sodium Chloride 0.9% is used to replace lost body fluids and salts, dilute other medicines, and/or act as a sterile liquid for washing wounds, nasal passages or during surgery.

For more information, see Section 1. Why am I using Sodium Chloride 0.9%? in the full CMI.

2. What should I know before I use Sodium Chloride 0.9%?

Do not use if you have ever had an allergic reaction to Sodium Chloride 0.9% or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Sodium Chloride 0.9%? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sodium Chloride 0.9% and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Sodium Chloride 0.9%?

• Sodium Chloride Injection 0.9% must only give by a doctor or healthcare professional. They will decide what dose and how long you will receive it for. This depends on your medical condition and other factors.

More instructions can be found in Section 4. How do I use Sodium Chloride 0.9%? in the full CMI.

5. What should I know while using Sodium Chloride 0.9%?

For more information, see Section 5. What should I know while using Sodium Chloride 0.9%? in the full CMI.

6. Are there any side effects?

Sodium Chloride 0.9% may cause nausea, vomiting, diarrhoea, cramps, decrease in saliva, tears or urination, increase in thirst and sweating, increase in heart rate, difficulty breathing or breathlessness which may worsen when lying down, swelling of hands, ankles and feet, dizziness, light headedness, drowsiness, restlessness or irritability, headaches, confusion, muscle weakness, twitching, rigidity or convulsions.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Sodium Chloride 0.9% solution for injection

Active ingredient: sodium chloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sodium Chloride 0.9%. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sodium Chloride 0.9%.

Where to find information in this leaflet:

1. Why am I using Sodium Chloride 0.9%?
2. What should I know before I use Sodium Chloride 0.9%?
3. What if I am taking other medicines?
4. How do I use Sodium Chloride 0.9%?
5. What should I know while using Sodium Chloride 0.9%?
6. Are there any side effects?
7. Product details

1. Why am I using Sodium Chloride 0.9%?

Sodium Chloride 0.9% contains the active ingredient sodium chloride. Sodium chloride is a mineral supplement.

Sodium Chloride 0.9% is used to:

• replace lost body fluids and salts
• dilute other medicines, which may be given by injection or drip
• act as sterile liquid for washing wounds, nasal passages, or during surgery

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use Sodium Chloride 0.9%?

Warnings

Your doctor will have considered the need to give you Sodium Chloride 0.9% carefully. Make sure to tell the doctor if you have any allergies.

Do not use Sodium Chloride 0.9% if:

• you are allergic to
  - sodium chloride
  - any other medicines
  - any other substance such as food dyes, preservatives or plastics.
  - any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue, or other parts of the body
• rash, itching or hives on the skin.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have or have had the following medical conditions:
  - heart problems
  - severe kidney disease
  - swelling of hands, ankles or feet due to excess fluid
  - breathlessness which may be severe or worsen when lying down
  - high blood pressure due to pregnancy
  - liver disease

You should not be given Sodium Chloride 0.9% if:

• the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear colourless solution.
• upon dilution with another IV solution the solution becomes cloudy, turbid, discoloured, or form visible particles.

If you are not sure whether you should be given Sodium Chloride 0.9% talk to your doctor.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Unless specifically prescribed by your doctor, you should not be given Sodium Chloride 0.9% if you are pregnant or breast feeding. Ask your doctor about the risks and benefits involved.

Use in Children

• Sodium Chloride 0.9% should be administered with care to very young patients.

Use in Elderly

• Sodium Chloride 0.9% should be administered with care to elderly patients.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking other medicines, including any medicines, vitamins or supplements that you by without a prescription from your pharmacy, supermarket, health food shop, herbalist or naturopath.

Some medicines may interfere with Sodium Chloride 0.9% and affect how it works.

These include:

• Corticosteroids
• or other drugs that cause sodium to be retained in the body.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sodium Chloride 0.9%.

4. How do I use Sodium Chloride 0.9%?

How much to use

• Your doctor or health care professional will decide what dose of Sodium Chloride 0.9% you will receive and how long you will receive it for. This depends on your medical condition and other factors.
• Sometimes only a single dose of Sodium Chloride 0.9% is required.

How to use Sodium Chloride 0.9%

• The way Sodium Chloride 0.9% will be used by your doctor or health care professional will depend on why you need it.
• Sodium Chloride 0.9% will only be opened when it is time for you to have the injection.

If you are given too much Sodium Chloride 0.9%

Overdose is unlikely to occur as Sodium Chloride 0.9% must only be given by a doctor or nurse. Your doctor or nurse will monitor the level of sodium and chloride in the blood. Some medical conditions may result in too much sodium or chloride in the body, and you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Sodium Chloride 0.9%?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Sodium Chloride 0.9%.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given Sodium Chloride 0.9%.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Sodium Chloride 0.9%. It may affect other medicines used during the surgery.

If you feel lightheaded or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from a bed or a chair, will help your body get used to the change in position and blood pressure. If this problem continues to get worse talk to your doctor.

Call your doctor straight away if you:

• become pregnant during the course of Sodium Chloride 0.9% treatment.

Remind any doctor, dentist, pharmacist or nurse you visit that you have been given Sodium Chloride 0.9%.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sodium Chloride 0.9% affects you.

Sodium Chloride 0.9% may cause dizziness, light-headedness, drowsiness, or weakness in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else dangerous.

Looking after your medicine

• Sodium Chloride Injection 0.9% will be stored in the surgery, pharmacy or ward of a hospital. The medicine is kept in a cool dry place where the temperature stays below 25°C.
• Sodium Chloride Injection 0.9% will only be opened when it is time for you to have the injection.
• It should not be stored after it is opened nor used for more than one person.

Keep it where young children cannot reach it.

6. Are there any side effects?

All medicines can have side effects. The use of Sodium Chloride 0.9% to replace lost body fluids and salts or addition to intravenous fluids is unlikely to result in any side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

If you are over 65 years of age or very young, you may have an increased chance of getting side effects.

Reporting side effects

After you have received medical advice for any side affects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Sodium Chloride 0.9% contains

Do not take this medicine if you are allergic to any of these ingredients.

Sodium Chloride 0.9% does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives.

What Sodium Chloride 0.9% looks like

Sodium Chloride 0.9% is a clear, colourless solution in:

• a clear glass 100 mL vial with a plastic green top. (AUST R 48349).
• a clear glass 50 mL vial with a plastic top. (AUST R 11975).

Who distributes Sodium Chloride 0.9%

Sodium Chloride 0.9% is supplied by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020.

This leaflet was prepared in Jul 2021.

Phebra and the Phi symbol are both trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS September 2021

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Each mL contains 9 mg sodium chloride equivalent to 0.15 mmol sodium ions and 0.15 mmol chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sodium chloride 0.9% is an isotonic solution for injection. pH 4.5 to 8.0. Osmolality of 296 mOsm/L.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of heat prostration or muscle cramps, chloride deficiency due to diuresis or salt restriction, prevention or treatment of extracellular volume depletion.

Parenteral.

Topical or irrigation.

4.2 Dose and Method of Administration

The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.
Use in one patient on one occasion only and discard. Contains no antimicrobial preservative. Solutions containing visible, solid particles must not be used.

4.3 Contraindications

Congestive heart failure.
Severe renal impairment.
Conditions of sodium retention and oedema.
Liver cirrhosis.
Irrigation during electrosurgical procedures.

4.4 Special Warnings and Precautions for Use

Do not use unless the solution is clear. The entire contents of the vial should be used immediately on opening. Do not store opened vials. Do not re-sterilise. Do not use on more than one patient.
Any solution remaining should be discarded.
When used as a vehicle for intravenous drug delivery, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.
Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid/ base balance may be necessary.
Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids or other drugs that may give rise to sodium retention.
Sodium chloride should be administered with care to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia and very young or elderly patients.

Special concerns.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Additives may be incompatible with sodium chloride.
Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Proper use of normal saline (0.9%) as a vehicle for parenteral drugs or as an electrolyte replacement is unlikely to result in adverse effects.

Mild hypernatraemia.

Hypernatremia.

Postoperative intolerance of sodium chloride.

Symptoms due to solution or administration technique.

Reporting suspected adverse reactions.

4.9 Overdose

Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.
Hydrochloric acid and/or sodium hydroxide are used for pH adjustment.
The injection does not contain - preservative.

6.2 Incompatibilities

Additives may be incompatible with sodium chloride.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG)¹. The expiry date can be found on the packaging.
¹ AUST R 78928, AUST R 11975, AUST R 48349.

6.4 Special Precautions for Storage

Sodium Chloride 0.9% 10 mL ampoule (AUST R 78928).

Sodium Chloride 0.9% 50 mL vial (AUST R 11975).

Sodium Chloride 0.9% 100 mL vial (AUST R 48349).

6.5 Nature and Contents of Container

Sodium Chloride 0.9% 50 mL glass vial is supplied in a carton containing 10 vials. Phebra product code - INJ069.
Sodium Chloride 0.9%** 100 mL glass vial is supplied in a carton containing 10 vials. Phebra product code - INJ072.
Sodium Chloride 0.9% 10 mL ampoule is supplied in a carton containing 10 ampoules. Phebra product code - INJ061.
Not all presentations may be marketed.
The vial stopper is not made with natural rubber latex.
** Injection/Irrigation solutions have a flip off/tear off top on the sterile vial.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Structural Formula: NaCl.
The molecular weight of the compound is 58.44

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes